Clinical trial Recruiting at 2 sites Interventional Ages 18 and up

Using sensory testing to predict treatment response in chronic pancreatitis

Official title: QST Study: Predicting Treatment Response in Chronic Pancreatitis Using Quantitative Sensory Testing

Run by University of Pittsburgh · NCT03434392 · Data updated 2026-11-12

This study is testing if a special pain sensitivity test can help predict how well people with chronic pancreatitis will respond to different treatments.

Quick facts

Study typeInterventional
Ages18 Years and up
SexAll
Enrollment500 (estimated)
SponsorUniversity of Pittsburgh
Academic / other
Locations2 sites (Baltimore, Maryland and 1 other locations)
StatusRecruiting
StartedOctober 24, 2017
Main results expectedJune 30, 2030
Study endsJune 30, 2031
Registry record updatedSeptember 11, 2026
Trial IDNCT03434392 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Ideal candidates include adults aged 18 and older with chronic pancreatitis or those with abdominal pain and no pancreatic disease.

Probably not a fit

Patients with pancreatic disease who do not experience abdominal pain or those unable to comply with study procedures may not benefit from this study.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study employs Quantitative Sensory Testing (QST) to evaluate pain patterns in patients with Chronic Pancreatitis (CP). By applying standardized stimulations, the study aims to map the pain system and identify different phenotypes of pain response. Participants will undergo QST alongside standardized questionnaires assessing pain, depression, anxiety, and quality of life. Follow-up testing will be conducted for those undergoing endoscopic or surgical therapy to assess changes in their pain profile over time.

Why it matters

Potential benefit: If successful, this approach could lead to more effective and personalized treatment strategies for patients suffering from chronic pancreatitis.

How similar studies have gone: Other studies utilizing similar sensory testing techniques have shown promise in understanding pain mechanisms, suggesting potential for success in this novel application.

Who can join: the full rules

Show full inclusion / exclusion criteria
Inclusion Criteria:

1. Subjects with no pancreatic disease and no abdominal pain, or patients with a diagnosis of functional dyspepsia.

   * Subjects are 18 years or older in age
   * Subjects must be able to read and understand the study information.
   * Personally signed and dated informed consent document indicating that the subject has been informed of all pertinent aspects of the study.
   * Subject is willing and able to comply with the scheduled visits, questionnaires, treatment plan, and other study procedures.
2. Suspected CPs Inclusion Criteria

   * Subjects are 18 years or older in age
   * Subjects with a) Indeterminate CP (Cambridge 1 or 2 on CT scan or MRI/MRCP) who have abdominal pain without prior history of AP, or b) those with acute (AP) or recurrent acute pancreatitis (RAP) who have recovered from their attack(s) of AP, whose imaging studies are either normal or show changes consistent with Cambridge classification of 1 or 2, and they have ongoing abdominal pain. Both diabetic and non-diabetic subjects will be allowed to enter the study.
   * Subjects must be able to read and understand the study information.
   * Subjects must suffer from abdominal pain suspected to be pancreatic origin with an intensity above 3 on the visual analogue scale (VAS, where 0=no pain and 10= intolerable pain), and meet the criteria for chronic pain (pain ≥ 3 days per week for at least 3 months).
   * Personally signed and dated informed consent document indicating that the subject has been informed of all pertinent aspects of the study.
   * Subjects willing and able to comply with the scheduled visits, questionnaires, and other study procedures.
3. Definite Chronic Pancreatitis - Inclusion Criteria

   * Subjects are 18 years or older in age
   * Subjects will have a prior confirmed diagnosis of CP on CT scan or MRI/MRCP according to Cambridge Classification (grade 3 or 4). Both diabetic and non-diabetic subjects will be allowed to enter the study.
   * Subjects must be able to read and understand the study information.
   * Personally signed and dated informed consent document indicating that the subject has been informed of all pertinent aspects of the study.
   * Subjects willing and able to comply with the scheduled visits, questionnaires, and other study procedures.
4. Sphincter of Oddi Dysfunction (SOD) Type 1 or Type 2 Inclusion Criteria

   * Subjects are 18 years or older in age
   * Subjects have prior diagnosis of Type 1 or Type 2 Sphincter of Oddi Dysfunction (subjects with biliary pain accompanied by biochemical features of transient biliary tract obstruction including elevated transaminases, alkaline phosphatase, or conjugated bilirubin; may also be accompanied by biliary or pancreatic ductal dilation on imaging)
   * Subjects must be able to read and understand the study information.
   * Personally signed and dated informed consent document indicating that the subject has been informed of all pertinent aspects of the study.
   * Subjects willing and able to comply with the scheduled visits, questionnaires, and other study procedures.

Exclusion Criteria:

1. Subjects with no pancreatic disease and no abdominal pain, or patients with a diagnosis of functional dyspepsia.

   * Subjects with evidence or history of medical or surgical disease of importance for this study as judged by investigator.
   * Subjects suffering from painful conditions that make them unable to distinguish the pain associated with CP from chronic pain of other origins.
   * Subjects with known pregnancy at the time of enrolment.
   * Subjects who have previously undergone surgical intervention on their pancreas.
2. Suspected CPs Exclusion Criteria

   * Subjects with evidence or history of medical or surgical disease of importance for this study as judged by investigator.
   * Subjects suffering from painful conditions other than pancreatitis or SOD type 1 or 2 that make them unable to distinguish the pain associated with pancreatitis or SOD from chronic pain of other origins.
   * Subjects with known pregnancy at the time of enrolment.
   * Subjects who have previously undergone surgical intervention on their pancreas.
3. Definite Chronic Pancreatitis Exclusion Criteria

   * Subjects with evidence or history of medical or surgical disease of importance for this study as judged by investigator.
   * Subjects suffering from painful conditions other than pancreatitis or SOD type 1 or 2 that make them unable to distinguish the pain associated with pancreatitis or SOD from chronic pain of other origins.
   * Subjects with known pregnancy at the time of enrolment.
   * Subjects who have previously undergone surgical intervention on their pancreas.
4. Sphincter of Oddi Dysfunction (SOD) Type 1 or Type 2 Exclusion Criteria

   * Subjects with evidence or history of medical or surgical disease of importance for this study as judged by investigator.
   * Subjects suffering from painful conditions other than pancreatitis or SOD that make them unable to distinguish the pain associated with pancreatitis or SOD from chronic pain of other origins.
   * Subjects with known pregnancy at the time of enrolment.
   * Subjects who have previously undergone surgical intervention on their pancreas.

Where it's running

  • Johns Hopkins Medical Institutions
    Baltimore, Maryland, United States
    Recruiting
  • University of Pittsburgh Medical Center
    Pittsburgh, Pennsylvania, United States
    Recruiting

Study contacts

  • Principal investigator: Anna Evans-Phillips, MD — University of Pittsburgh
  • Study coordinator: Anna Evans-Phillips, MD
  • Email: evansac3@upmc.edu
  • Phone: 412-624-4560

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.